Open, Classified

Masimo LNCS TC-I SpO2, Reusable Ear Sensor, REF: 1895

FDA Recall Z-1985-2023 · Posted 2023-06-21

Recalling FirmMasimo Corporation

Recall StatusOpen, Classified

Product CodeDQA

Date Initiated2023-04-21

Product Quantity443,799 units

Reason for Recall

TC-I tip clip sensor may produce readings outside the accuracy specification.

Firm Action

On 5/17/2023, Masimo issued a Urgent: Medical Device Recall Notice via FedEx. Masimo asked consignees to take the following actions: 1. Contact Masimo Technical Services to request return of the affected part and lot number(s) for replacements and/ or if you have part numbers or lot numbers not included in this communication and have questions about those parts. 2. Masimo s Technical Services is available Monday through Friday 6:00am -5:00pm PST for live assistance or 24 hours a day to leave a message and someone will contact you. Local contact information can be found at http://service.masimo.com. 3. Complete Attachment 1, then email it to [email protected], or Fax it to 1-949-297-7575 by MM DD, 2023. 4. Any adverse reaction or quality problems experienced with the use of this product may be reported to the FDA s MedWatch Adverse Event Reporting program online, by regular mail or by fax.

Root Cause

Nonconforming Material/Component

Distribution Pattern

US: AK , AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY OUS: Argentina, Australia, Austria, Belgium, Bermuda, Brazil, Canada, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Ecuador, Finland, France, Germany, Gibraltar, Guernsey, Hong Kong, Hungary, Iceland, India, Israel, Italy, Japan, Jersey, Jordan, Kenya, Lebanon, Malaysia, Malta, Mexico, Morocco, Netherlands, New Zealand, Norway, Oman, Palestinian Territory, Poland, Portugal, Puerto Rico, Qatar, Russian Federation, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Vietnam.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K051212MODIFICATION TO LNCS OXIMETRY SENSORSMasimo Corporation · 2005-07-12

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.